Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

Recruiting Phase 3 Interventional Study
Chagas Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Laboratorio Elea Phoenix S.A. · Industry
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About This Trial
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of c…
Trial Locations
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Eligibility Criteria
Inclusion criteria (Subjects must meet ALL the inclusion requirements listed below to enter the study): * Signed informed consent form; * Between ≥18 and ≤60 years of age; * Weight ≥ 50 kg to ≤ 95 kg; * Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two t…
Contacts

Carola Lombas, MD

(54) 11 44898300

carola.lombas@elea.com

CONTACT

Tayná Marques, MSc

(55) 21 9978 40503

tmarques@dndi.org

CONTACT